Senior Regulatory CMC Consultant – ADC Linker-Payload Drug Substance
6-Month Contract (Renewable) Remote – Europe
Opportunity
An exciting opportunity has arisen for an experienced Senior Regulatory CMC Consultant to support a late-stage oncology programme focused on Antibody Drug Conjugates (ADCs). This is a high-impact consultancy position where you will lead the global regulatory strategy for the linker-payload drug substance component of an innovative ADC programme as it progresses towards major regulatory submissions.
Working within a collaborative Regulatory CMC environment, you will play a critical role in ensuring that the drug substance regulatory package is submission-ready for both European and US health authorities.
This is a fully remote position within Europe offered initially as a 6-month contract with strong likelihood of extension.
Key Responsibilities
Lead Regulatory CMC strategy for the ADC linker-payload drug substance
Provide strategic guidance for global regulatory submissions, including FDA and EMA marketing applications
Drive development and review of Module 3 drug substance documentation
Ensure compliance with current ICH, FDA and EMA regulatory expectations
Support health authority interactions and responses to regulatory questions
Collaborate extensively with CMC, Analytical Development, Process Development, Quality and Manufacturing teams
Contribute to regulatory risk assessments and mitigation strategies
Provide expert advice on drug substance control strategies, specifications, characterisation and stability packages
Support programme teams through critical development and submission milestones
Candidate Profile
Essential Experience
Approximately 10 years or more of Regulatory CMC experience
Strong background in drug substance development
Proven experience leading CMC drug substance aspects of global regulatory submissions
Deep understanding of Module 3 Quality documentation
Excellent working knowledge of ICH, FDA and EMA regulatory requirements
Experience supporting late-stage development or registration programmes
Highly Desirable
Antibody Drug Conjugate (ADC) experience
Linker-payload development experience
Highly potent API (HPAPI) experience
Bioconjugate or complex biologics experience
Experience supporting Marketing Authorisation Applications (MAA), BLAs or equivalent global filings
EU Rate - €500-€600 p/day
Regulatory, CMC, ADC, drug, substance, submission, antibody, conjugate, BLA, MAA, marketing, authorisation, FDA, EMA, module